Hi @alee

A non-inferiority test that results in a "statistically non-significant difference" is a form of statistical analysis and would be required to support such a conclusion, and it is not appropriate to conclude non-inferiority (or similarity) based on nonsignificant test result in a study designed only for superiority as noted in the Guidance Document for Claims Based on Non-Inferiority Trials. The appropriate interpretation of this observation is that the test product failed to achieve statistical significance for superiority (i.e. it would not be considered a “positive clinical outcome”), which does not support a claim of “similarity”. Please also note that all clinical claims must be pre-defined, directionally consistent with the primary endpoint (confirmed through statistical evidence), and similar to the description in the domains section, overall scores require statistical significance as per sections 3.4, 3.5 and 3.6 of the Guidance document for the Use of Patient Reported Outcomes in Advertising, respectively .

Hey @maryssa
There is currently no limit on number of “keywords”. 🙂

Hello @jdilly11

Yes. The internet (web banner to website) would be considered the same tool/directly linked to the web based banner ad. Note that they should be taken directly to the highest level (i.e. not a landing page with a link to the highest) and there should be no additional effort (e.g. they are not required to pass a gate. They should have already been validated as an HCP to see the banner ad.).

Hello @alee

Provision 8 of the Guidance Document for Claims Based on Kaplan Meier Analysis does not apply to retrospective studies. The Guidance on Real-World Evidence/Data is intended for RWE/D and does not apply to (Kaplan-Meier analyses in) randomized, controlled trials. The use of multivariate analyses to identify prognostic factors associated with overall survival pertaining to a drug product may provide insights for future investigation but it also creates implications for subgroups with specific patient/disease characteristics that would not be acceptable in the absence of pre-planned evaluation of these subgroups (s. 1.4 of the Guidance on Real-World Evidence/Data for RWE/D and s. 3.1.1 of the PAAB Code for randomized, controlled trials).

Hello @jennifer_cm

An attestation letter from Med/Reg confirming that only sites which have been approved will be listed is sufficient. When submitting, provide a standardized template of how the sites will be listed. This will allow sites to be added and removed without a need to re-review as this becomes an administrative feature.

Good Afternoon @mimi77

Please see PAAB Q&A 173, 467, 729.

Hey @laraholmes

All claims, whether implicit (e.g., conveyed through visuals) or explicit, must be supported within the piece. For "before and after" images, data must be provided to quantify the magnitude of the effect suggested by the visuals and should appear at or before the images. Additionally, the images must accurately reflect the data presented, rather than showcasing the best-case outcomes observed in the study.

Hey @maryssa

A search of the PAAB resources at paab.ca should turn up “What constitutes current medical opinion”. A search of “guidelines” on the forum should turn up 593, 743, 77, among other results. HTH.

@jennifer-carroll Thank you kindly for the clarification - this is helpful.

Thank you so much @jennifer-carroll for your detailed answer! I’ll probably send an email then with the eFile number and additional details soon.

Hey @constance. Please find response below.

Phase 1 is not complete. There will be rounds of consultation with industry prior to launching to ensure that we are developing as efficiently and in the most supportive manners. Please stay tuned as we look for assistance in finalizing technical validations, user testing, and ensuring adequate support resources are in place. We anticipate these steps will be completed by the end of Q2 and will communicate a go live date as we approach completion.

Manufacturers have been informed about the initiative through communications and the townhall. PAAB has also spoke to this initiative at a number of conferences. We have also invited manufacturers to reach out with specific questions especially surrounding privacy and security. We anticipate that the level of understanding may vary. The purpose of the debrief meeting is to ensure that both agencies and manufacturers have a shared understanding of the initiative while also inviting feedback and suggestions as we develop and scale. As their agencies, your role is pivotal in supporting their implementation efforts, but the debrief aims to equip everyone with the necessary context and clarity to move forward confidently. Please rest assured that we will develop training and guidance related to the new policies and procedures to ensure both agencies and manufacturers are equipped with the knowledge they need to successfully utilize the new features’.

We anticipate that there will be a mixture of manufacturers alone and agencies in collaboration with the manufacturers participating in these meetings. Who participates is at the discretion of the manufacturer. If agencies have agency specific questions, we are also happy to set up these meetings. It may also be possible that the first meeting will be solely with the manufacturer and then they may opt to bring in agencies as it becomes necessary. Please note that currently, these debriefs are not training sessions for the use of new features. These debriefs are intended to discuss security, privacy, and whether/how proprietary manufacturer generated content will be used as we progress through Phase 1 and 2 of the initiative”.

We hope that helps. Thank you for the questions and continued engagement.

@mgregory

Our apologies. The above was posted prematurely.

Please note that as per PAAB code 7.3.1a, "The URL may be supplemented, but not replaced, by an electronic coding system, such as a QR code or a bar code".

For print media, please be reminded that the telephone number must be accompanied with the URL +/- the QR code.

Hi @maryssa

Although 'price' generally refers to the monetary amount associated with the patient's acquisition of the sponsor's prescription product, insurance coverage and corporate service programs addressing acquisition costs could also potentially be presented in a manner that complies with the name, price, and quantity restriction. Acceptability of the proposed claim in the above question may be possible depending on the balance of the context. This can be addressed during the review process.

@jennifer-carroll Thank you 🙂 this helps!

Hi @dnewman

The “Health Canada Distinction between advertising and other activities” document addresses Canadian conferences and International conferences held in Canada. General corporate APS informing HCPs of upcoming international conferences (print or digital) may be distributed to Canadian HCPs and may be subject to PAAB review per code section 7.4, depending on the content. Use in branded material would require PAAB review and may be limited to avoid linkage issues. Material (including digital), emanating from the international conference outside of Canada or from the global division of the pharmaceutical company, is outside the scope of PAAB.

Hey @vt

Yes, you should ensure that the 4 criteria are still followed. These criteria still exist in the distinction document, they are just mentioned across the document and therefore not repeated in this section.

For example, the “Content and Context Factors” section in the “Overview” states:
• A message involving unauthorized health products or unauthorized indications, in a context such as educational activities, may be considered promotional if:
• the message does not caution that the product’s safety and effectiveness are still under investigation and that Health Canada has not yet granted market authorization

Within the Educational Activities section, things that could make the piece promotional are:
• The limitations of the data and of the health products are not adequately discussed
• Reports, edited scripts or recorded videos of the proceedings, in whole or in part, that concern a health product are disseminated by the sponsor or its agent to a wider audience

These are in addition to the copy under the revised heading of “Canadian and International Conferences”. In general, if it is a Canadian conference, the content should be created by the Canadian office. If it is an international conference, the content should be created by the parent company and should be adequately disclaimed. Remember that the distinction document is not intended to be an exhaustive list, but a set of guiding principles with examples throughout to help assess context and content. The examples in the “Overview” section should be considered when evaluating individual activities.

Hello @dmauri

The guidance does not apply to NOC/c products and therefore has no bearing on data reviews for NOC/c products. The standard NOC/c approach remains the same (see Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOC/c)). If the data or study are presented within the TMA, we will allow it in the same context within promotional pieces. When assessing copy similar to “the results of the extension study were consistent with those of the earlier analysis”, clarity on which endpoints and the same tonality and direction will be required. Additional comments may arise pending review of the language used throughout the TMA.